8:02 AM ET 1/27/12 | Briefing.com
This submission was based on efficacy and safety data from Study 200, a single-arm
study of bosutinib in over 500 patients with previously treated Ph+ CML,
including patients resistant or intolerant to imatinib as well as patients who
were previously treated with dasatinib or nilotinib. Currently, there are no
approved therapies available for CML patients after second-line treatment with
dasatinib or nilotinib. Bosutinib is an oral, once-daily, investigational dual
Src and Abl kinase inhibitor with minimal inhibitory activity against c-kit and
PDGFR. It is believed that, by dual inhibition of the Src and Abl tyrosine
kinases, bosutinib may inhibit signaling in CML cells that allows the cells to
grow, survive and reproduce.